The FDA has sent out an early alert to J&J’s Abiomed unit and its manufacturing partner Oscor for their catheter introducer kits that are used with Impella heart pumps amid manufacturing concerns.
These concerns center on potential sheath leakage from the device, which is used to establish catheters into the body. It is part the company’s Impella heart pump kit.
“The unexpected leakage in these locations is due to certain manufacturing issues that increase the risk of access-site bleeding,” the FDA said in its alert.
“This may cause blood loss requiring medical intervention, such as device exchange or removal, manual compression, and, in some cases, blood transfusion,” the regulator added.
As of April 22, Abiomed had reported eight instances of major bleeding and “three complaints that have corresponding patient deaths,” but the company found that the deaths “are not attributable to introducer leakage,” according to the FDA.
The FDA alert comes after Abiomed and Oscor sent out their own letter to affected customers recommending all Introducer Kits used with Impella heart pumps be corrected prior to continued use.
The FDA is recommending that while hospitals may continue to use existing inventory, they should “consider a device exchange or using the repositioning sheath to minimize blood loss if potential leakage is observed.”
For Abiomed, the FDA alert comes just days after the agency issued a recall notice for Impella controllers.